The US FDA QMSR Transition - 21 CFR 820 and ISO 13485

Description

The US FDA, after years of discussing the harmonization of 21 CFR 820, Device CGMPs (QSR), to the ISO 13485, Device QUS, has finally moved closer to implementation. On February 22, 2022, they published a draft regulation that harmonizes 21 CFR 820 with ISO 13485:2016, called the Quality Management System Regulation (QMSR).

The FDA has been working to align its QSR with the worldwide quality systems standard ISO 13485. Part of the reason for harmonizing its regulations with ISO 13485 is to reduce the regulatory burden for device makers who sell product in both the US and in EU / Asia, by eliminating redundancies involved in complying with both the ISO and QSR standards. After years of reviews, the Agency has “determined that the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the current Part 820, providing a similar level of assurance…